FDA — authorised 30 October 2018
- Application: BLA761071
- Marketing authorisation holder: SANDOZ INC
- Local brand name: HYRIMOZ
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA authorised HYRIMOZ on 30 October 2018
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 30 October 2018.
SANDOZ INC holds the US marketing authorisation.